Explore best practices for effective medical device post-market surveillance implementation.
Introduction The landscape of medical device regulation is evolving rapidly, with post-market surveillance (PMS) emerging as a critical component in ensuring patient safety and device efficacy. Approximately 70% of medical instruments in Brazil undergo continuous oversight, underscoring the necessity of robust PMS practices. This article explores best practices for implementing effective post-market surveillance systems, illustrating how manufacturers can navigate regulatory requirements while enhancing product performance and safeguarding patient well-being. However, with the complexities of data collection and risk management, manufacturers must consider: How can they effectively balance compliance with innovation in their surveillance strategies? Define Post-Market Surveillance and Its Importance in Medical Devices Post-market surveillance (PMS) is a systematic method for tracking the security and efficacy of , which is essential for after their market authorization. This is essent…